BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUDS HIV-1

    MDR report key: 408235 · Received July 25, 2002

    Report

    Report Number
    1037802-2002-00003
    Event Type
    Other
    Date Received
    July 25, 2002
    Date of Event
    June 10, 2002
    Report Date
    July 24, 2002
    Manufacturer
    MUREX DIAGNOSTICS, INC.
    Product Code
    LRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON 06/2002 THE ACCOUNT REPORTED A NEGATIVE SUDS HIV-1 RESULT WITH LOT #2030 ON A PATIENT DIAGNOSED AS HIV-1 POSITIVE. THE SAMPLE WAS SENT FOR WESTERN BLOT TESTING WHICH CAME BACK INDETERMINATE. A SECOND SAMPLE WAS DRAWN ONE WEEK LATER AND WAS SUDS HIV1 NEGATIVE AND WESTERN BLOT REACTIVE. A THIRD SAMPLE WAS DRAWN TWELVE DAYS AFTER THIS AND WAS SUDS HIV1 POSITIVE AND WESTERN BLOT REACTIVE. THE ACCOUNT CONTACTED THE REFERENCE LAB WHICH PERFORMED THE WESTERN BLOT TESTING AND THEY STATED THAT THE PATIENT WAS UNDERGOING SEROCONVERSION. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUDS HIV-1 EIA FOR THE DETECTION OF ANTIBODY TO HIV TYPE 1 LRM MUREX DIAGNOSTICS, INC. NA 2030

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN